November 22, 2012

New Documents Detail The Ineffective Regulation Efforts Of The FDA In The Meningitis Outbreak

by editor

Lawrence LeBlond for redOrbit.com - Your Universe Online

New details have emerged over the US Food and Drug Administration´s (FDA) ineffective efforts to regulate a Massachusetts drug maker that has been at the center of the national meningitis health crisis this year.

The deadly meningitis outbreak, which has so far sickened close to 500 people, and has killed 34, is directly linked to steroidal injections produced by Massachusetts-based New England Compounding Center. In documents released Tuesday, the FDA said it would use its full authority to force NECC into compliance, only to back down because of lack of jurisdiction.

The NECC cooperated with FDA inspectors in some instances and promised it would improve its drug making procedures, but at other times defied the agency´s authoritative stance and refused to provide records and continued to ship drugs out with no concerns on safety.

Congressional committees, which held hearings on the meningitis outbreak last week, had reviewed the documents and criticized the FDA for failing to act on information about the unsafe practices at the company as far back as 2002. According to the documents, it took the FDA 684 days to issue a warning letter after uncovering infractions at the compounding facility in 2002. In return, the NECC chastised the FDA in a January 2007 letter, calling the agency out for taking 18 months longer than the its average response time to issue a warning.

"We believe that FDA's nearly two year delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products," NECC co-owner and chief pharmacist Barry Cadden said in the letter, released by the FDA under an open records request through the Freedom of Information Act.

In an October 2008 letter, the FDA acknowledged there had been a “significant delay” in its response but insisted that the delay “in no way diminishes our serious concerns about your firm's operations.”

Erica Jefferson, a spokeswoman for the FDA said on Wednesday that the delay in issuing a warning letter was due to the agency´s limited authority on the issue.

"During the time between the inspection of NECC and the issuance of the warning letter, there was ongoing litigation pertaining to pharmacy compounding and significant internal discussion about how to regulate compounders, all of which delayed FDA," she said.

By law, compounding pharmacies are regulated at the state level, rather than by federal authority. But because these types of pharmacies have grown so large in recent years and have become major suppliers to hospitals and medical facilities all across the country, the FDA was seeking for clearer authority on policing them. But some lawmakers in Congress believed the FDA already had enough power to handle the issue. And a November 19 congressional panel meeting told the FDA not to expect new authority until all documents have been released.

On November 20, defense lawyers for NECC´s owners told a US District Judge in Boston there was nothing to show they had a direct hand in the cause of the meningitis outbreak. But the company´s efforts to defy attempts by regulators to enforce compliance has further tainted the image of a company that has had numerous violations as far back as 1999.

Meanwhile, further testing by the FDA on steroidal injections produced by NECC has turned up more contaminants in additional drugs. The agency has updated its list of lot numbers for contaminated drugs produced by compounding pharmacy after finding unknown fungal growths and bacteria in triamcinolone and betamethasone. However, there have been no known reports of infections in these drugs. So far, all illnesses of meningitis have been linked to preservative-free methylprednisolone acetate administered in epidurals or joint injections as a treatment for pain.

The U.S. Centers for Disease Control and Prevention (CDC) is "unaware of infections among patients that can be definitively linked to exposure to these drugs," Curtis Allen, a spokesman for the CDC, told Tom Wilemon at USA Today.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the bacterial contaminants in betamethasone and triamcinolone are not recognized pathogens.

"They are environmental bacteria that are present just everywhere in the environment," Schaffner said. "You can find them on inanimate surfaces. You can find them out in the soil and the like. They obviously should not be in these medications. Could this bacteria, however, if inoculated produce an infection? On occasion they could. But they are not what we call professional pathogens."

Even Exserohilum rostratum, the fungus behind the meningitis outbreak, had never been known to cause such an illness until it was introduced into patients through spinal injections, he noted.

Ongoing inspections at NECC by the FDA and Massachusetts Board of Pharmacy have found several possible sources for the contamination, including leaking water, uncontrolled temperature and dirty conditions. Also found were equipment soiled with greenish-yellow residue, according to inspection reports.